Status:
RECRUITING
Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Hepatocellular Carcinoma (HCC)
Esophageal Varices
Eligibility:
All Genders
20-90 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate whether endoscopic variceal ligation (EVL) or carvedilol is more effective at preventing the first esophageal variceal bleeding (EVB) in patients with he...
Detailed Description
Gastro-esophageal variceal bleeding is a major complication of portal hypertension (PHT) and carries a high rate of rebleeding and mortality. Hepatocellular carcinoma (HCC), a special subgroup of PHT,...
Eligibility Criteria
Inclusion
- \- Patients with HCC and high-risk EVs, confirmed through imaging and clinical data (classified as F2 or F3 EVs according to Beppu et al. classification)
Exclusion
- Age less than 20 years or greater than 90 years.
- History of esophageal variceal bleeding.
- Previous treatment for EVs, including EVL, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt (TIPS), or surgical interventions.
- Use of non-selective β-blockers within two weeks prior to enrollment.
- Contraindications for non-selective β-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, poorly controlled diabetes, and severe peripheral artery disease.
- Presence of other end-stage organ diseases, including terminal cancers other than HCC, heart failure, and renal failure.
- Pregnant women.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06594744
Start Date
October 1 2024
End Date
October 1 2030
Last Update
February 13 2025
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217